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510(k) K192891

Laparoscope Lens Shield Device (LENS) by Medeon Biodesign, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2019
Date Received
October 10, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Medeon Biodesign, Inc.

  • K200902 — ClickClean (April 30, 2020)
  • K193652 — AbClose - Port Site Closure Device (March 26, 2020)
  • K170103 — Laparoscope Lens Shield Device (LENS) (February 16, 2017)
  • K160117 — AbClose - Port Site Closure Device (September 9, 2016)
  • K160172 — Laparoscope Lens Shield Device (April 21, 2016)
  • K151117 — Laparoscope Lens Shield Device (August 20, 2015)

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